FDA.reportPublic FDA data

Hydromorphone Hydrochloride

Product NDC
0409-1304
11-digit product format
004091304
Labeler code
0409
Product ID
0409-1304_a3ebafac-648e-47b1-a6f5-1e3bff1e3e08
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROMORPHONE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Hospira, Inc.
Application
NDA200403
Marketing category
NDA
Marketing start
2011-12-01
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
4 mg/mL
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydromorphone Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROMORPHONE HYDROCHLORIDE4 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL960UP2KRW
Rxcui897653, 897753, 897756, 897757, 897758, 1724276, 1724383, 1724644

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c92985da-a658-b186-e763-2287eda87a86Product name320250221
96c475b3-58c7-b955-d715-0111804a3e50Product name520210512
1dd54659-b775-4fa8-a858-7f0e521fbadcProduct name420200925
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-1304-03Hydromorphone Hydrochloride1 mL in 1 CARTRIDGEINJECTION, SOLUTION133
0409-1304-31Hydromorphone Hydrochloride10 in 1 CARTONINJECTION, SOLUTION1033

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1304-03ML - Milliliter0409-13046f07fa93-6220-4841-ae87-964f76ae733412018-01-12
0409-1304-31ML - Milliliter0409-13041a25bf84-8db6-438a-b5fa-ed44856c3f9b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROMORPHONE HYDROCHLORIDEACTIVE INGREDIENTL960UP2KRWHYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]12
HYDROMORPHONEACTIVE MOIETYQ812464R06HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]12
LACTIC ACID, UNSPECIFIED FORMINACTIVE INGREDIENT33X04XA5ATHYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]12
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XHYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]12
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IHYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]12
SODIUM LACTATEINACTIVE INGREDIENTTU7HW0W0QTHYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1304HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]30Current NDC, Legacy NDC, 2 package rows20241206_e9c9ef18-7dfc-4322-b2fc-29b934c30f8b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1724383HYDROmorphone HCl 1 MG in 1 ML CartridgePSNe9c9ef18-7dfc-4322-b2fc-29b934c30f8b33
897653HYDROmorphone HCl 1 MG in 1 ML InjectionPSNe9c9ef18-7dfc-4322-b2fc-29b934c30f8b33
897756HYDROmorphone HCl 1 MG in 1 ML Prefilled SyringePSNe9c9ef18-7dfc-4322-b2fc-29b934c30f8b33
1724644HYDROmorphone HCl 2 MG in 1 ML CartridgePSNe9c9ef18-7dfc-4322-b2fc-29b934c30f8b33
1724276HYDROmorphone HCl 2 MG in 1 ML InjectionPSNe9c9ef18-7dfc-4322-b2fc-29b934c30f8b33
897757HYDROmorphone HCl 2 MG in 1 ML Prefilled SyringePSNe9c9ef18-7dfc-4322-b2fc-29b934c30f8b33
897758HYDROmorphone HCl 4 MG in 1 ML CartridgePSNe9c9ef18-7dfc-4322-b2fc-29b934c30f8b33
897753HYDROmorphone HCl 4 MG in 1 ML InjectionPSNe9c9ef18-7dfc-4322-b2fc-29b934c30f8b33
17243831 ML hydromorphone hydrochloride 1 MG/ML CartridgeSCDe9c9ef18-7dfc-4322-b2fc-29b934c30f8b33
8976531 ML hydromorphone hydrochloride 1 MG/ML InjectionSCDe9c9ef18-7dfc-4322-b2fc-29b934c30f8b33
8977561 ML hydromorphone hydrochloride 1 MG/ML Prefilled SyringeSCDe9c9ef18-7dfc-4322-b2fc-29b934c30f8b33
17246441 ML hydromorphone hydrochloride 2 MG/ML CartridgeSCDe9c9ef18-7dfc-4322-b2fc-29b934c30f8b33
17242761 ML hydromorphone hydrochloride 2 MG/ML InjectionSCDe9c9ef18-7dfc-4322-b2fc-29b934c30f8b33
8977571 ML hydromorphone hydrochloride 2 MG/ML Prefilled SyringeSCDe9c9ef18-7dfc-4322-b2fc-29b934c30f8b33
8977581 ML hydromorphone hydrochloride 4 MG/ML CartridgeSCDe9c9ef18-7dfc-4322-b2fc-29b934c30f8b33
8977531 ML hydromorphone hydrochloride 4 MG/ML InjectionSCDe9c9ef18-7dfc-4322-b2fc-29b934c30f8b33
1724383hydromorphone HCl 1 MG per 1 ML CartridgeSYe9c9ef18-7dfc-4322-b2fc-29b934c30f8b33
897653hydromorphone HCl 1 MG per 1 ML InjectionSYe9c9ef18-7dfc-4322-b2fc-29b934c30f8b33
897756hydromorphone HCl 1 MG per 1 ML Prefilled SyringeSYe9c9ef18-7dfc-4322-b2fc-29b934c30f8b33
1724644hydromorphone HCl 2 MG per 1 ML CartridgeSYe9c9ef18-7dfc-4322-b2fc-29b934c30f8b33
1724276hydromorphone HCl 2 MG per 1 ML InjectionSYe9c9ef18-7dfc-4322-b2fc-29b934c30f8b33
897757hydromorphone HCl 2 MG per 1 ML Prefilled SyringeSYe9c9ef18-7dfc-4322-b2fc-29b934c30f8b33
897758hydromorphone HCl 4 MG per 1 ML CartridgeSYe9c9ef18-7dfc-4322-b2fc-29b934c30f8b33
897753hydromorphone HCl 4 MG per 1 ML InjectionSYe9c9ef18-7dfc-4322-b2fc-29b934c30f8b33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-1304-03004091304031 mL in 1 CARTRIDGE1 mlHistorical
0409-1304-310040913043110 CARTRIDGE in 1 CARTON (0409-1304-31) / 1 mL in 1 CARTRIDGE (0409-1304-03) 10 cartridge2011-12-010000-00-00NoNoCurrent